Senior Quality Assurance Associate III

2 weeks ago


Irvine, California, United States BioDuro-Sundia Full time

Compensation Range: $69,971-110k

About Us

BioDuro-Sundia stands as a leading Contract Research, Development, and Manufacturing Organization (CRDMO) on a global scale, employing over 2,200 professionals. Our operations are primarily based in the United States, with our headquarters located in Irvine, CA. We operate 7 facilities worldwide, delivering comprehensive solutions and outstanding services to our clients for complex preclinical and clinical trial initiatives. Our expertise encompasses Drug Discovery, Development, and Manufacturing, establishing BioDuro-Sundia as a preferred partner in the industry.

Why Choose BioDuro-Sundia?

Advance your career with BioDuro-Sundia and play a pivotal role in transforming lives through the innovative products we assist in developing. Here, you will leverage your skills on impactful projects that enhance the lives of patients globally while growing personally and professionally alongside a team of experienced professionals and emerging talents. Our core values—Accountability, Respect, Tenacity, Results, and Integrity—are integral to our operations. Regardless of your position, BioDuro-Sundia is committed to empowering all employees and providing the essential resources to drive our continuous journey towards excellence.

Position Overview

As a Senior Associate III in Quality Assurance, you will be responsible for supporting pharmaceutical product evaluations, which include in-process testing, product release, stability assessments, and method validation. Your duties will encompass reviewing master and executing batch records, conducting investigations and reviews of product nonconformance, performing quality audits, analyzing product stability data, and approving specifications for raw materials and packaging components while ensuring compliance with Good Manufacturing Practices (GMP).

Qualifications

The ideal candidate will possess a Master's degree (or equivalent) in Chemistry, Pharmaceutics, or a related field, along with a solid understanding of analytical quality control testing, preparation of Standard Operating Procedures (SOPs), review of stability data, and experience with experimental and engineering batches in oral solid dose manufacturing.



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